Study to Evaluate Safety of C-1101 Versus Sterile Saline in Adults With Chronic Painful Lumbosacral Radiculopathy
RecruitingPhase 1NCT07264270
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The purpose of this study is to evaluate the safety and tolerability of C-1101 administered as a single dose, transforaminal epidural injection compared to sterile saline
Study details
- Official title
- A Phase 1, Randomized, Double-Blind, Single Dose Escalation Study to Assess the Safety and Tolerability of Transforaminal Epidural Administration of C-1101 Versus Sterile Saline in Adults With Chronic Painful Lumbosacral Radiculopathy
- Conditions
- Lumbosacral Radicular Pain
- Sciatic Radiculopathy
- Sciatic Leg Pain
- Sciatica
- Lumbosacral Radicular Syndrome
- Lumbosacral Radiculopathy
- Interventions
- Drug: C-1101
- Other: Placebo: Sterile Saline
- Sponsor
- Consano Bio
- Start date
- 2025-12-03
- Primary completion
- 2026-11-01
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- Australia
- Total sites listed
- 3
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Diagnosis of painful LSR (sciatica) radiating to or below the knee, with an inadequate response to conservative care * Body mass index \< 35 kg/m2. Exclusion Criteria: * Presence of clinically significant disease or any other painful condition that may interfere with assessments. * Any condition that currently requires blood or platelet transfusions. * Diagnosed with schizophrenia, bipolar disorder, or major depressive disorder. * Increased risk of bleeding or is taking anticoagulants or platelet aggregation inhibitors. * History or presence of autonomic neuropathy, diabetic neuropathy, or other peripheral neuropathies. * History of myocardial infarction within the last 6 months or congestive heart failure. * The presence of an active malignancy or tumor. * Have undergone a surgical procedure for back pain. * Recent use of immunosuppressants, oral steroids, or intravenous steroids.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07264270